{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T19:22:52Z","timestamp":1791660172420,"version":"4.3.4"},"reference-count":21,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T00:00:00Z","timestamp":1750982400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Tuberculosis (TB) remains a major public health problem globally, as reflected in persistently high morbidity and mortality rates. Current control efforts have been further complicated by the ongoing SARS-CoV-2 (COVID-19) pandemic. Rapid molecular diagnostics remain crucial to identifying the millions of people with undiagnosed TB.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The study aimed to determine the diagnostic accuracy of Truenat MTB Ultima\/COVID-19 for the detection of COVID-19 and TB among presumptive TB participants, using a microbiological reference standard (MRS) and a country-approved real-time reverse transcription polymerase chain reaction (RT-PCR) COVID-19 assay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective cohort study assessed the diagnostic accuracy of the Truenat MTB Ultima\/COVID-19 multiplex test among adults with presumptive TB, enrolled from healthcare facilities in four countries, aiming to reach 270 confirmed TB cases. The inclusion criteria were as follows: adults who self-reported at least one symptom suggestive of pulmonary TB, were willing to return for a day 2 visit, and agreed to provide oral swab samples for bio-banking. Patients were excluded from enrolment in the study if they had started anti-TB treatment within 60\u202fdays or TB preventive therapy within 6\u202fmonths prior to enrolment or if they were unable to provide 3\u202fmL of sputum or nasopharyngeal (NP) and tongue swab samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Expected outcome<\/jats:title><jats:p>This study expected to obtain point estimates of the sensitivity and specificity of the Truenat MTB Ultima\/COVID-19 multiplex test for TB and COVID-19 detection, compared to Xpert Ultra, among presumptive TB participants using an MRS and pre-defined COVID-19 assay.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2025.1620210","type":"journal-article","created":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T05:31:23Z","timestamp":1751002283000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Performance evaluation of the Molbio diagnostics Truenat MTB Ultima\/COVID-19 multiplex assay for TB and COVID-19 case detection among people with symptoms suggestive of tuberculosis\u2014a study protocol for clinical trials"],"prefix":"10.3389","volume":"13","author":[{"given":"Manju","family":"Purohit","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Willy","family":"Ssengooba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Cox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar","family":"Ugarte-Gil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Sserubiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hafsah","family":"Tootla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kavindhran","family":"Velen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Sz\u00e9kely","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Penn-Nicholson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,6,27]]},"reference":[{"key":"ref1","article-title":"Global 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